Suture material for pneumatic suture instrument

ABSTRACT

The surgical suturing instrument incorporates a pressurized fluid suture feed system for passing a suture through the instrument and the tissues to be joined thereby. A fluid jet in communication with a suture feed conduit selectively entrains a suture in a stream of pressurized fluid, which carries the suture through the instrument&#39;s hollow tissue penetrating needle. The tissue penetrating needle may be shaped to direct the suture&#39;s free end to a point external the body cavity. Alternatively, a suture return conduit may be provided to engage the hollow tissue penetrating needle to receive and carry the suture&#39;s leading end to a point external the body cavity. External or internal pressurized fluid sources are utilized. A surface irregularity proximal the suture&#39;s leading end enhances the entrainment of the suture with the fluid stream. Individual, cartridge and spool fed sutures may all be utilized.

TECHNICAL FIELD

This invention relates to the field of suturing instruments used forstitching internal tissues of the body, such as in arthroscopic orendoscopic surgery. More particularly, the invention relates to asuturing instrument wherein the suture is fed through the instrument andthe tissues to be joined by entrainment with a pressurized fluid. Thepreferred suture contemplated by the invention will have a surfaceirregularity to provide an enhanced frictional interface to facilitateentrainment in the fluid stream.

BACKGROUND OF THE INVENTION

In the field of arthroscopic surgery various suturing instruments havebeen used 11 for stitching internal tissues of the body. An object ofsuch surgical procedures is to minimize the invasiveness of the surgicalinstrument in performing a given surgical procedure, whether diagnosticor restorative. This object is achieved by making a small incision inthe overlying tissue layers to provide the surgeon access the site ofinterest. The surgeon may then insert the surgical instrument throughthe small incision and perform the desired procedure.

In many procedures, the surgeon will need to insert a stitch to joinbody tissues at the site of interest. A suturing instrument such as thatdisclosed by Caspari, et al., in U.S. Pat. No. 4,957,498, will typicallybe used for joining tissues internal a patient's body. Such suturinginstruments provide a hollow tissue penetrating needle through which thesurgeon feeds a length of suture material. The suture material is fed bymanipulation of a thumbwheel. After insertion of the suture materialthrough the tissues the free end of the suture material is withdrawnwith the instrument through the incision to a point external thepatient's body. The surgeon then knots the suture material andmanipulates the suture material to urge the knot back through theincision to a point adjacent to the joined tissues.

In practicing the invention disclosed by Caspari, the inventor hasnoticed the difficulty experienced by surgeons in manipulating thesuture feed mechanism while maintaining the jaws of the instrument inthe closed, tissue penetrating position. Moreover, the instrumentdisclosed by Caspari et al, requires the surgeon to coax the free end ofthe suture material to a point external the patient's body while at thesame time feeding additional suture material by manipulation of thethumb wheel.

Should the surgeon loose the free end of the suture material duringretraction of the instrument, additional intrusion into the body cavityis necessary to retrieve the suture free end for tying the desiredstitch. In addition, should the free end of the suture be inadvertentlypulled free of the tissue penetration points, additional tissue insultmay be necessary to reinsert the suture material through the tissues.Accordingly, there is a need for a suturing instrument that provides animproved suture material feed and retraction mechanism.

BRIEF SUMMARY OF THE INVENTION

It is an object of the invention contemplated herein to provide animproved suture material feed mechanism for a surgical suturinginstrument. According to the present invention, a pressurized fluidsource is utilized to entrain and selectively feed a suture through theinstrument and the tissues to be joined thereby. The suturing instrumentcomprises a handle portion, an elongated tubular member extending fromthe handle portion and a hollow tissue penetrating needle attached tothe elongate tubular member distal the handle portion. A suture feedconduit extends in fluid communication between the hollow tissuepenetrating needle and a suture feed inlet proximal the handle portion.A fluid jet, proximal the handle portion selectively communicates apressurized fluid through the suture feed conduit and tissue penetratingneedle. The suture feed inlet receives a leading end of the suture suchthat it is positioned relative the fluid inlet jet for selectiveentrainment of the suture with the pressurized fluid.

A preferred suture according to the present invention includes a surfaceirregularity, which defines a friction enhancing interface between thesuture and the pressurized fluid. The surface irregularity is providedproximal a leading end of the suture and enhances the entrainment of thesuture in the pressurized fluid stream. According to the presentinvention, the suture may be supplied to the instrument as an individualstrand or as a plurality of sutures in a continuous strand. Each type ofsuture may be supplied on a spool or cartridge received by theinstrument.

Individual suture strands are provided at a predetermined lengthcorresponding to a required penetration depth to stitch the site ofinterest and should also allow the free ends of the strand to remainexternal the body for the surgeon to easily tie and manipulate the knotto a point adjacent the tissues to be joined.

A continuous strand of suture material has a plurality of surfaceirregularities spaced apart along its length. Each surface irregularityis spaced at a predetermined distance corresponding to a requiredpenetration depth to stitch the site of interest and also allow the freeends of the strand to remain external the body for the surgeon to tieand manipulate the knot. A notch in the suture material adjacent asubsequent abrasion or protrusion is provided to facilitate separationof a delivered strand of suture material from the remaining strand ofsuture material.

Since it is a further object of the invention to improve the extractionof the suture free end to a point external the body, the suturinginstrument of the present invention provides for a suture materialreturn path between the site of interest and the instrument entryincision. This is achieved by reversing the direction of the fed sutureand directing it on a suture return path to a point external thepatient's body via the instrument entry incision.

In situations where a cannula is used to retract tissues overlying thesite of interest open, the cannula opening may be used as the returnpath. In this instance, a hook shaped needle redirects the fed suturematerial outward the body. In situations where a cannula is not used, orwhere other organs or tissues may overly the site of interest, a returnconduit is provided on the instrument to receive the leading end of thesuture and carry it outwardly of the instrument entry incision. Positivereception of the suture material in the return conduit is provided byhaving the suture return conduit selectively engage with the tip of thetissue penetrating needle. Engagement of the return conduit with thetissue penetrating needle is provided by a lever or scissors assemblyoperable from the handle of the instrument.

Additional objects and advantages of the invention will be realized byreference to the accompanying drawings and the detailed description ofthe drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of my invention are depicted in the appendeddrawings which form a part of this disclosure and wherein:

FIG. 1 is a side sectional view of a suture instrument with a tissuepenetrating needle in an open position;

FIG. 2 is a side sectional view of a suture instrument with a tissuepenetrating needle in an open an a spooled suture feed;

FIG. 3 is a side view of a suture instrument with a tissue penetratingneedle in a closed position;

FIG. 4 is a side sectional view of a suture instrument with a tissuepenetrating needle in a closed position;

FIG. 5 is a detail view of a sleeve actuated tissue penetrating needleclosure with the needle in an open position;

FIG. 6 is a detail view of a sleeve actuated tissue penetrating needleclosure with the needle in an open position;

FIG. 7 is a detail view of a lever actuated tissue penetrating needleclosure with the needle in an open position;

FIG. 8 is a detail view of a lever actuated tissue penetrating needleclosure with the needle in an open position;

FIG. 9 is a detail view of a scissors actuated tissue penetrating needleclosure with the needle in an open position;

FIG. 10 is a detail view of a scissors actuated tissue penetratingneedle closure with the needle in an open position;

FIG. 11 is a detail view of an extensible suture return conduit tissuepenetrating needle closure with the needle in an open position;

FIG. 12 is a detail view of an extensible suture return conduit tissuepenetrating needle closure with the needle in an open position;

FIG. 13 is a detail view of an open hook tissue penetrating needle;

FIG. 14 is a side view of an abraided suture surface irregularity;

FIG. 15 is a side view of a constriction suture surface irregularity;

FIG. 16 is a side view of a protruding suture surface irregularity; and

FIG. 17 is a side view of a compound suture surface irregularity.

FIG. 18 is a partial side view of depicting a typical surgical procedureutilizing a hooked embodiment of the claimed suture instrument;

FIG. 19A is a side view of a suture spool;

FIG. 19B is a perspective view of a suture spool;

FIG. 20A is a perspective view of a suture cartridge;

FIG. 20B is a partial sectional view of a suture cartridge with a woundsuture material in its pre-insertion condition;

FIG. 20C. is a partial sectional view of a suture cartridge with a woundsuture material in its inserted condition;

FIG. 21A is a partial sectional view of a suture cartridge with a foldedsuture 11 material in its pre-insertion condition;

FIG. 21B. is a partial sectional view of a suture cartridge with afolded suture material in its inserted condition;

FIG. 22 is a partial perspective view of a cartridge receiving sutureinstrument;

FIG. 23 is a partial perspective view of a cartridge receiving sutureinstrument with a cartridge inserted;

FIG. 24 is an end view of a suture instrument handle with an internalpressurized fluid source; and

FIG. 25 is an end view of a suture instrument handle configured for anexternal pressurized fluid source.

DETAILED DESCRIPTION OF THE INVENTION

In reference to the drawings, the suture instrument 10 of the presentinvention comprises a handle portion 20, an elongated tubular member 30extending from handle portion 20 and a hollow tissue penetrating needle40 located at an end of elongated tubular member 30 distal handleportion 20. The length of elongated tubular member 30 is selected tocorrespond with a desired penetration depth within a body to reach thetissues to be joined 11 by a suture 50. The tissues to be joined 11 willalso be referred to herein as site of interest. As is well known in theart, a cannula 12, such as that depicted in FIG. 18, is often used toretract the tissues at the entry incision 13 and improves access to thesite of interest 11 by retracting the tissues overlying the site ofinterest 11. Cannula 12 will also perform a protective role for theoverlying tissues by preventing undesirable instrument contact with thesame. Accordingly, the length of elongated tubular member 30 must alsoaccount for any extension of canula 12 external the patient's body.

Handle portion 20 is adapted to be received in the hand of a surgeon tofacilitate 11 manipulation of the tissues at the site of interest andtheir suturing with instrument 10. Handle portion 20 is depicted in thedrawings substantially perpendicular to elongated tubular member 30.However, this depiction is merely exemplary, as it is contemplated thatmore ergonomically advantageous handle configurations may be utilizedfor a particular surgical procedure or surgeon preference withoutdeparting from the scope of the present invention.

In practice, the surgeon manipulates the instrument to position hollowtissue penetrating needle 40 at a desired penetration point and urgesthe needle tip 41 through the first tissue to be joined. The surgeonthen manipulates the instrument to a desired penetration point on asecond tissue to be joined and urges needle tip 41 through the secondtissue. Depending on the needle tip configuration, examples of which areprovided in FIGS. 5-12, the surgeon will manipulate a trigger 27, suchas that shown in FIGS. 1-4, or a conventional scissors assembly (notshown). Suture 50 may then be passed through the instrument and thetissues to be joined.

In the prior art, the surgeon was required to continuously manipulatethe instrument during delivery of suture 50 through the instrument.Similarly, the surgeon must manipulate the instrument to continue todeliver suture 50 while coaxing free end 51 to a point external thepatient's body. The pressurized fluid suture delivery taught by thepresent invention eliminates the need to manipulate the instrumentduring suture 50 delivery through the tissues and subsequent passage ofleading end 51 to a point external the patient's body.

In the present invention, a suture feed conduit 31 extends betweenhandle portion 20 and tissue penetrating needle 40. A suture feed inlet32 is provided at a first end of suture feed conduit 31 proximal handleportion 20. Suture feed inlet 32, suture feed conduit 31 and hollowtissue penetrating needle 40 define a suture delivery path. A fluid jet33, in communication with suture feed conduit 31, selectivelycommunicates a pressurized fluid through suture feed conduit 31 andhollow tissue penetrating needle 40. Suture 50 is positioned to beentrained in the pressurized fluid stream for delivery through thetissues to be joined.

Fluid jet 33 is conveniently positioned in handle 20 and comprises afluid jet inlet 23 and a fluid jet outlet 28, with fluid jet inlet 23receiving a pressurized fluid source 21, provided by a cylinder 21received in handle 20, as shown in FIG, 24, or from a source externalthe instrument 10, such as a pump or a pressurized fluid outlet commonin an operating room environment and operatively connected to sutureinstrument 10, as shown in FIG. 25.

Fluid jet outlet 28 is positioned at an angle relative suture feedconduit 31 such that, upon release of the pressurized fluid source, avacuum is induced at said suture feed inlet 23. Once suture 50 leadingend 51 is positioned relative fluid jet 33 depression of activationbutton 24, permits the pressurized fluid to be delivered through fluidjet 33 and suture 50 is entrained with the pressurized fluid and passedthrough the instrument and the tissues to be joined. Delivery of leadingend 51 to a point external a patient's body is provided by directingleading end 51 through a suture return path.

Referring to FIGS. 14-17, a preferred suture 50 will have a surfaceirregularity 53 positioned proximal leading end 51. Surface irregularity53 is shaped to define a friction enhancing interface between the suturesurface 54 and the pressurized fluid, facilitating entrainment of suture50 with the pressurized fluid. As shown in FIG. 14, surface irregularity53 is an abrasion or tuft on suture surface 54. As shown in FIG. 15,surface irregularity 53 comprises a constriction 55 in the crosssectional surface area of suture 50. Surface irregularity 53 may also bedefined by a protrusion or bend 56 of suture material raised from thesurface of the suture 50, as shown in FIG. 16. Similarly, theconstriction 55 of FIG. 15 and the protrusion 56 of FIG. 16 may becombined to define the compound surface irregularity 53 depicted in FIG.17. Each embodiment is suitable for use on individual suture strands,i.e. each strand will produce an individual stitch.

For continuous strands of suture material from which the surgeon may cutindividual suture strands after retraction of instrument 10, a pluralityof surface irregularities 53 are provided spaced apart along the lengthof suture 50. Each irregularity 53 is separated by a distancecorresponding to a particular site of interest 11. The separationdistance will depend upon the size of the patient and the depth of thesite of interest 11 and also will allow the leading end 51 and trailingend 52 to be accessible to the surgeon at a point external the patient'sbody.

For continuous suture strands, the embodiments including a constriction55 are particularly desirable. If a sufficient reduction in the crosssectional surface area is provided, constriction 55 will define a sutureseparator point, permitting the surgeon to readily sever an individualsuture strand by pulling and snapping the trailing end 52 of thedelivered preceding strand from the remaining length of suture material.

In addition to manually inserting a single suture strand 50, variousmethods are available for providing a suture 50 for use with sutureinstrument 10. As shown in FIG. 2, a spool 70, containing a strand ofwound suture material 50 may be received in handle 20 such that leadingend 51 may be positioned proximal fluid jet 33 for entrainment in thepressurized fluid stream. Alternately, as shown in FIGS. 21-23, suture50 may be received in a cartridge 55 by winding, folding, or otherwise.Cartridge 55 may then be inserted into handle 20 such that sutureleading end 51 is positioned proximal fluid jet 33 for entrainment inthe pressurized fluid stream.

As shown in FIGS. 19A and 19B, spool 70 comprises, a spool windingsurface 73 interposed between an inner spool face 72 and an outer spoolface 74. A bore 71 may be provided for rotation about a spindle inhandle 20. Handle 20 is adapted to receive spool 70 for axial rotationtherein by any means known in the mechanical arts such as a spindle,bearing race or otherwise. To facilitate proper insertion of spool 70into handle 20, the diameter of inner spool face 72 may be sized smallerthan the diameter of outer spool face 74. Inner and outer faces 72, 74may also have chamfered surfaces 78, and 75 respectively, facinginwardly to winding surface 73 to facilitate winding of the spools withsuture 50. Moreover, the chamfered surface 75 on outer spool face 75 mayalso provide a bearing/seal interface between it and a correspondingrace (not shown) provided in handle 20. A spool end cap 76 may alsoextend from the outer face 74 to assist in providing a sealinginterface. A knob 77 extends from end cap 76 to permit manual rotationof spool 70 for positioning suture leading end 51 proximal fluid jet 33.

In reference to FIGS. 20 and 21, cartridge 55 comprises a suturereservoir 56, a coupler 57, and a protective cap 58. Preferably, coupler61 is integrally formed with reservoir 63 to limit the presence of smallloose articles in the operating room environment, thereby reducing thepossibility of inadvertent introduction of foreign matter through anopen incision. Reservoir 56 is a hollow member having an open end and aclosed end and receives a length of suture 50 therein. A small bore 59extending through the closed end may be provided to improve entrainmentof suture 50. Protective cap 58 is also a hollow member having at leastone open end and attaches with coaxial alignments to suture reservoir 56via coupler 57. In its pre-insertion condition, protective cap 58receives leading end 51 and a portion of suture 50 therein sufficient toposition leading end 51 proximal fluid jet 33 upon insertion ofcartridge 55 into the instrument. Protective cap 58 may be detachablycoupled to reservoir 56, however, to reduce the presence of loosearticles in the operating room environment, protective cap 58 should becaptively attached to suture reservoir 56.

As shown in FIGS. 20B-C and 21A-B, protective cap 58 is captively andslidably received within suture reservoir 56 such that as cartridge 55is inserted into handle 20, protective cap 58 retracts within reservoir56, thereby permitting insertion of leading end 51 proximal fluid jet33. In this configuration, an interference fit between coupler 57 andprotective cap 58 maintains protective cap 58 in position duringshipment and storage of cartridge 55, while permitting protective cap 58to retract during insertion of cartridge 55 into handle 20. To ensureproper delivery and to prevent bunching or binding of suture 50 asprotective cap 58 retracts into suture reservoir 56, a portion ofprotective cap 58 should also extend into suture reservoir 56 andreceive a forward portion of the wound or folded suture material 50. Inaddition to joining protective cap 58 to suture reservoir 56, coupler 57also provides a coupling interface between cartridge 55 and a suturefeed inlet 32 on the instrument handle 20, as shown in FIG. 23.

The coupling interface may be an interference fit, an index slot, or anysimilar arrangement. The protective cap may also be closed at one endopposite the open end joined to suture reservoir 56. Preferably apierceable membrane (#) closes this end to enhance the sterility ofcartridge 55. In this instance, suture feed inlet 32 may have asharpened extension for piercing membrane ( ) as cartridge 55 is affixedto instrument 10.

As discussed previously, a cannula 12 may be employed to retract entryincision 13 and the tissues overlying the site of interest 11. In thiscase, a simplified embodiment of suture instrument 10 is provided asdepicted in FIG. 13. In this simplified suturing instrument 10, hollowtissue penetrating needle 40 is hook shaped to reverse the suturedelivery path. Tip 41 is positioned to direct leading end 51 back intothe cavity 14 defined by cannula 12 for projection of suture leading end51 to a point external the patient's body. The surgeon may then graspleading end 51 and retract the instrument from the body. As the surgeonretracts the suture instrument, additional suture 50 material is drawnthrough the instrument. As discussed above, if suture 50 is anindividual strand, the length of suture 50 should be such that itstrailing end 52 will be drawn free of the instrument 10 once theinstrument has been withdrawn from cannula 12. The surgeon may thengrasp trailing end 52, then tie and manipulate knot 53 to a pointadjacent the tissues to be joined 11. If suture 50 is provided in acontinuous strand, the surgeon may withdraw a length suture materialfrom the instrument before severing the suture free of the instrument10.

In the preferred embodiments of suturing instrument 10, the suturereturn path is provided by the instrument itself. The suture return pathis defined by a suture return conduit 36 having a receiving end 37,selectively engageable with tip 41 of hollow tissue penetrating needle40, and a discharge end 38 proximal handle portion 20. Suture 50,entrained in the pressurized fluid is received by suture return conduit36 at receiving end 37 and carried thereby to discharge end 38. Assuturing instrument 10 is retracted, suture 50 is draw from suture feedconduit 31 and suture return conduit 36 until leading end 51 andtrailing end 52 are free of the instrument. The surgeon may then tie andmanipulate knot 53 adjacent the site of interest 11.

In the embodiment depicted in FIGS. 1-6, elongated tubular member 30comprises a selectively extensible sleeve 60, operable by a lever 61,extensibly coupled to handle portion 20 at a sleeve receiver 65. Suturereturn conduit 36 and suture feed conduit 31 are received internalsleeve 60. Sleeve 60 terminates at a flared portion 62 proximal tissuepenetrating needle 40 and receiving end 37 of suture return conduit 36.Actuation of lever 61 extends sleeve 60, such that flared portion 61urges receiving end 37 and needle 40 into cooperative engagement.

In the embodiment depicted in FIGS. 7 and 8, an actuator lever 63 ispivotally connected to sleeve 60 and selectively urges receiving end 37into cooperative engagement with a stationary needle 40. An actuator rod64 or cable operatively connects actuator lever 63 with lever 21operative from handle portion 20. By selecting a resilient material forsuture return conduits, biasing means at leaver 21 may be eliminated.Preferably, actuator rod 64, suture feed conduit 31 and suture returnconduit 36 are received within sleeve 60.

In the embodiment depicted in FIGS. 9 and 10, a conventional scissorsassembly may be utilized. In the embodiment depicted in FIGS. 11 and 12,hollow tissue penetrating needle 40 is hook shaped, with tip 41 directedtowards handle portion 20. Suture return conduit 36 is extensiblerelative handle 20 for cooperative engagement of receiving end 37 withneedle 40. In this instance trigger 27 may be operatively connected tosuture return conduit 36, permitting selective positioning of theconduit 36 relative needle 40. Alternatively, a conventional scissorsassembly may be employed without detracting from the utility of theinvention.

The specific embodiments and features discussed herein and shown in theaccompanying drawings are exemplary of a suture instrument according tothe present invention. As such many variations or modifications may bemade without departing from the scope of the of the appended claims.

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 8. In a suture, comprising an elongate strand of surgically suitable material for surgically joining body tissues, said suture having a leading end, a trailing end, and a suture surface, the improvement comprising a surface irregularity defined on said suture surface proximal said leading end, said surface irregularity defining a friction enhancing interface between said suture surface and a fluid stream passing over said suture surface, whereby said suture is entrained in said fluid stream.
 9. The suture of claim 8, further comprising a plurality of surface irregularities spaced apart at a predetermined distance corresponding to a desired working length of said suture.
 10. The suture of claim 9, wherein said suture further comprises a suture separator point proximal a subsequent surface irregularity, said separator point defined by a substantial constriction in the transverse area of said suture.
 11. The suture of claim 8, wherein said surface irregularity is defined by a bead of said surgically suitable material.
 12. The suture of claim 8, wherein said surface irregularity is defined by a tuft of said surgically suitable material.
 13. The suture of claim 8, wherein said surface irregularity is defined by a constriction of said surgically suitable material.
 14. A cartridge for receiving a suture comprising an elongate strand of surgically suitable material for joining body tissues, said cartridge comprising; a suture reservoir, a protective cap, and a coupler; said suture reservoir comprising an elongate hollow member having an open end and a closed end; said protective cap comprising an elongate hollow member having at least one open end; and said coupler comprising a releasably joining interface between said open end of said suture reservoir and an open end of said protective cap.
 15. The cartridge of claim 14, where in said protective cap is detachable from said coupler.
 16. The cartridge of claim 14, wherein said open end of said protective cap is slidably received through said open end of said suture reservoir.
 17. The cartridge of claim 14, wherein said coupler is integrally formed with said suture reservoir.
 18. The cartridge of claim 14, wherein a said suture reservoir releasably receives a length of said suture.
 19. The cartridge of claim 17, wherein said suture reservoir releasably receives a wound length of said suture.
 20. The cartridge of claim 17, wherein said suture reservoir releasably receives a folded length of said suture.
 21. The cartridge of claim 17, wherein a leading end of said suture extends through said open end of said suture reservoir and said leading end is received in said protective cap.
 22. The cartridge of claim 16, wherein said protective cap further comprises a pierceable membrane sealed end distal said suture reservoir.
 23. The cartridge of claim 17, wherein said coupler is releasably engagable with a suture feed inlet of a surgical instrument for joining body tissues with said suture after.
 24. The cartridge of claim 22, wherein said instrument comprises an elongate tubular member, a handle attached at a proximal end of said elongate tubular member and a hollow tissue penetrating needle attached at a distal end of said elongate tubular member, a suture feed conduit extending between said suture feed inlet proximal said handle and an inner bore of said hollow tissue penetrating needle, a pressurized fluid suture feed means for entraining said suture in a pressurized fluid stream and communicating said suture through said instrument, said hollow tissue penetrating needle, and said body tissues to be joined.
 25. (canceled) 